Examining the Feasibility of Prolonged Ketone Concentrate Supplement Drink Consumption in Adults With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- To determine the feasibility of conducting a randomized controlled trial (RCT) on the effects of consumption of a ketone supplement in adults with type 2 diabetes in free-living environment for 90 days: Recruitment rate of participants into the trial
Study Overview
Brief Summary
Brief Summary:
Ketones are a source of energy and signaling molecule that are produced by the body when not consuming any food or consistently eating a low-carbohydrate "keto" diet. Blood ketones can be used as a source of energy by the body, but they may also act as signals that impact how different cells in the body function.
Recently, ketone supplements have been developed that can be consumed as a drink. These supplements can raise blood ketones without having to fast or eat a "keto" diet. Previous studies have shown that these supplement drinks can lower blood sugar without having to make any other dietary changes. Drinking these ketone supplements may therefore be an effective strategy to improve blood sugar control and influence how cells function.
To find out if it is feasible for people with type 2 diabetes to drink these ketones supplements regularly over 90 days, we will compare between two groups in this study: one group that will be asked to drink ketone supplements, and one group that will be asked to drink a placebo supplement.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosed with type 2 diabetes by a physician at least 1 year prior
- •stable use of glucose-lowering medications for at least three months
- •must be able to read and understand English in order to complete the study questionnaires
Exclusion Criteria
- •competitively trained endurance athlete
- •actively attempting to gain or lose weight
- •having a history of mental illness or existing neurological disease
- •having a history of cardiovascular events in the last two years, hypoglycemia, irritable bowel syndrome, or inflammatory bowel disease
- •are currently taking SGLT2 inhibitors or insulin
- •are using more than 2 classes of glucose-lowering medication
- •currently following a ketogenic diet or regularly taking ketone supplements
- •unable to commit to a 90-day trial
- •being unable to follow remote guidance by internet or smartphone
- •currently taking natural or over-the-counter supplements specifically designed to lower blood glucose (e.g., berberine, bitter melon)
Arms & Interventions
Experimental: Exogenous Ketone Supplement
Participants will be instructed to consume a total of 177 mL of the exogenous ketone supplement drink (for a total of 30 g of beta-hydroxybutyrate) per day (3 doses at 59 mL containing 10 g of beta-hydroxybutyrate each) for a period of 90 days.
Intervention: Dietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediol (Dietary Supplement)
Placebo Comparator: Inert placebo
Participants will be instructed to consume an equivalent volume (177 mL) of taste- and volume-matched placebo per day (3 doses at 59 mL) for 90 days.
Intervention: Inert placebo (Other)
Outcomes
Primary Outcomes
To determine the feasibility of conducting a randomized controlled trial (RCT) on the effects of consumption of a ketone supplement in adults with type 2 diabetes in free-living environment for 90 days: Recruitment rate of participants into the trial
Time Frame: Start of enrolment to completion of enrolment
A recruitment rate of at least 4 participants per month (which will ensure the study is fully enrolled within a 1-year timeline) will be acceptable.
To determine the feasibility of conducting such an RCT: Compliance as measured by the self-reported volume of ketone supplement drink consumed
Time Frame: Across the 90-day intervention period (days 0 through 90)
≥ 67% of the drinks provided being consumed by participants as determined via self-report (i.e., an average of two out of three drinks per day being consumed) will be acceptable.
To determine the feasibility of conducting such an RCT: Retention as measured by the number of participants that complete the study
Time Frame: Across the 90-day intervention period (days 0 through 90)
≤ 30% of recruited participants dropping out of the study will be acceptable
Secondary Outcomes
- Measures of glycemic control (HbA1c)(Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up))
- Measures of glycemic control (glucose variability)(Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks))
- Gastrointestinal distress(Days 1, 45, and 90)
- Self-reported waist circumference(ay 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up))
- Levels of perceived hunger(Days 0 (pre-intervention/baseline), 45, and 90)
- Self-rated health(Days 0 (pre-intervention/baseline), 45, and 90)
- Theory of planned behaviour(Days 0 (pre-intervention/baseline) and 45)
- Measures of glycemic control (postprandial glucose area under the curve)(Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks))
- Hematology panel(Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up))
- Lipid panel (triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high density lipoprotein cholesterol, cholesterol/high-density lipoprotein cholesterol ratio)(Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up))
- Levels of physical activity(Days 0 (pre-intervention/baseline) and 45)
- Cravings(Days 0 (pre-intervention/baseline), 45, and 90)
- High-sensitivity c-reactive protein(Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up))
- Sleep quality(Days 0 (pre-intervention/baseline), 45, and 90)
- Overall acceptability(Day 90 or in case of withdrawal)
- Measures of glycemic control (average daily glucose)(Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks))
- Self-reported body weight(Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up))
- Self-reported energy consumption(Days 0 (pre-intervention/baseline), 45, and 90)
- Self-reported blood pressure (systolic and diastolic)(Days 0 (pre-intervention/baseline), 45, and 90)
- Supplement acceptability(Days 1, 45, and 90)
- Liver enzymes (ALT, AST)(Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up))
Investigators
Jonathan Little
Professor
University of British Columbia